A landmark NHS trial involving Sheffield Teaching Hospitals NHS Foundation Trust shows a purpose-designed prostate cancer lifestyle programme protected men from side effects of treatment, is low-cost, and can be rolled out across the NHS as a part of core prostate cancer care.
Findings from 'STAMINA', the largest trial of its kind, published in The Lancet Oncology, show that a purpose-designed lifestyle programme offering structured exercise, dietary advice and behavioural support delivered as part of routine cancer care reduced deterioration in quality of life in men undergoing treatment for prostate cancer by up to one third.
Analysis of the cost-effectiveness of the STAMINA programme, which was designed to be prescribed alongside routine prostate cancer care, found it provided benefits at a cost significantly below the threshold for NHS cancer funding.
The success in improving patients' quality of life in the trial demonstrates that STAMINA is ready for implementation across multiple NHS Trusts, the authors say.
How STAMINA worked
Funded by the National Institute for Health and Care Research (NIHR) and sponsored by Sheffield Teaching Hospitals NHS Foundation Trust, STAMINA involved multiple NHS and academic partners across the UK and was led by Sheffield Hallam University. Nuffield Health acted as the national delivery partner.
The trial recruited 700 men with prostate cancer across 15 NHS hospitals in England receiving androgen deprivation therapy (ADT), which lowers testosterone to slow the growth of prostate cancer.
However, due to its castrate effects, ADT can cause adverse effects including fatigue, increased central obesity, loss of muscle mass, reduced bone density, cardiovascular risk, and psychological distress, all significantly affecting quality of life.
Around 600,000 men in the UK are living with prostate cancer, with about half prescribed ADT at some point in their treatment pathway. The number of men living with prostate cancer has also surged by 20 per cent in the last five years, according to latest estimations.
Patients on the trial received an enhanced version of routine care offered by the NHS, or the STAMINA Lifestyle Intervention. This included a combination of supervised aerobic and resistance exercise, dietary advice, and behavioural support across 18 Nuffield Health Fitness and Wellbeing clubs.
NHS staff involved in the trial received additional training to recognise men who would benefit, recommend exercise and make a referral to Nuffield Health personal trainers, who were upskilled by the STAMINA programme to work as clinical exercise specialists.
Optimising quality of life
The adherence rate to the STAMINA exercise programme was high, with over 80 per cent of men attending their scheduled sessions over 12 months. Those participants attending the programme had better cancer-specific outcomes, such as better quality of life, and reported less fatigue compared with men receiving enhanced routine care. This clinically meaningful benefit was also sustained across core physical, functional, emotional, and social wellbeing quality of life domains over the 12-month period.
Furthermore, statistical modelling undertaken by the research team showed that the intervention was cost-effective and would be less expensive to provide than National Institute for Health and Care Excellence (NICE) value-for-money for cancer treatments. The STAMINA intervention also has a very high chance of being cost-effective for up to 10 years, even when account for staff training.
On the back of the trial's success, Nuffield Health has launched a new Cancer Activity Programme, working with Sheffield Hallam University and NHS Trusts to make a version of STAMINA available for men with prostate cancer, and planning to expand the programme to breast and bowel cancer patients, funding 50,000 places by 2030.
As the first lifestyle intervention integrated into routine cancer care at scale across the NHS in England, the STAMINA programme had an immediate impact for patients. Investigators from the study argue it should now serve as a template for integrating lifestyle interventions into cancer care in other complex health systems internationally.
'A huge step forward'
| Professor Derek Rosario was the trial's Chief Investigator
Professor Derek Rosario, Chief Investigator of STAMINA and Consultant Urological Surgeon at Sheffield Teaching Hospitals NHS Trust, said: "The importance of optimising quality of life for men with prostate cancer cannot be overstated. As well as the direct individual benefit, we know that optimising quality of life and mitigating fatigue through exercise has potential beneficial effects on overall survival. As the first lifestyle intervention integrated into routine cancer care at scale across the NHS in England, the findings of the STAMINA trial are a huge step forward and will make an immediate impact for patients, providing compelling evidence to clinicians who have been crying out for an evidence-based intervention to recommend their patients on ADT who present all the time with devastating treatment-related side effects.
"The evidence from this trial also satisfies NICE recommendations and those of expert reference groups across the world in mitigating devastating, but essential treatment-related side effects of those on ADT. I would like to thank all our patients, partners and participants for their enthusiasm and professionalism in delivering this programme."
Professor Liam Bourke, Academic Programme Director of STAMINA at Sheffield Hallam University, said: "STAMINA is a huge achievement - it has taken us nearly two decades of incredibly hard work to get here - and it offers a definitive step-change in how lifestyle programmes should be considered and integrated comprehensively into routine prostate cancer care. As the largest trial of its kind ever to be conducted, and the first to be designed to work in the NHS from day one. This makes the study really unique and ensures that the positive outcomes of the research will be delivered exactly where they need to be - to NHS patients during routine care."
Professor Lucy Chappell, Chief Scientific Adviser to the Department of Health and Social Care and CEO of the NIHR, said: "Cancer care is about so much more than just treating the disease, though this is of course still a huge priority. It's about supporting the whole person through their treatment and beyond. The NIHR is committed to funding vital evidence-based research such as this, which can be integrated directly into frontline healthcare to improve patients' quality of life."
STAMINA was led by Sheffield Hallam University and Sheffield Teaching Hospitals NHS Foundation Trust, working with Queen Mary University of London, the University of Leeds, the University of Sheffield, University of Bristol, University of York, University of Edinburgh, Cardiff University and Nuffield Health as the national delivery partner for the STAMINA lifestyle intervention.
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